The German lipoprotein apheresis registry - summary of the thirteenth annual report
V J J Schettler, N Selke, S Jenke, T Zimmermann, W Bernhardt, F Heigl, I Loehlein, R Klingel, B Hohenstein, U Schatz, A Vogt, G SchlieperAbstract
Background
In 2012, the German Lipoprotein Apheresis Registry (GLAR) was established, providing real-world data of lipoprotein apheresis (LA) treatment for a duration of 13 years, now. All patients in this registry fulfill German reimbursement guidelines demanding maximally tolerated and LDL-C targeted lipid-lowering therapy encompassing statins, ezetimibe, bempedoic acid, and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors before approval of the LA indication.
Methods
During the time period from 2012 to 2025, 92 German apheresis centers registered retrospective and prospective observational data of a total of 2,515 patients undergoing regular LA treatment for hypercholesterolemia or/and Lipoprotein(a)-(Lp(a))-hyperlipoproteinemia suffering from progressive atherosclerotic cardiovascular disease (ASCVD). Complete data sets of 996 patients including more than 74,700 LA sessions were subject of this registry analysis.
Results
In 2024, all patients treated with LA demonstrated a significant immediate median reduction rate of LDL-Cholesterol (LDL-C) (69.7%) and Lp(a) (75.0%). Patient data were analyzed for the incidence rate of major coronary events (MACE) and major non-coronary events (MANCE) 1 to 5 years before the beginning of LA treatment (y-5 to y-1) and prospectively up to twelve years on LA treatment (y+1 to y+13). During the first two years of LA treatment (y+1 and y+2) a MACE reduction of 81% was observed. This rate continued to be low during y+3 to y+13 analyzing LA patients with complete data sets. LA patients with high Lp(a) levels (Lp(a) ≥ 60 mg/dl (≥120 nmol/l) and an LDL-C < 100 mg/dl (< 2.6 mmol/l)) before the 1st LA session had a higher MACE reduction (92%; n=526) in the first two years of LA treatment compared to LA patients with increased LDL-C-levels (LDL-C ≥ 100 mg/dl (≥ 2.6 mmol/l) and Lp(a) < 60 mg/dl (< 120 nmol/l)) (47%; n=171). Essentially identical effects of LA were observed for MANCE with weaker event reduction. Adverse events of LA treatment remained low (< 5%) over the thirteen years and mainly represented vascular access problems (0.9%). No side effects resulted in termination of regular LA therapy.
Conclusions
The current analysis of the GLAR data demonstrates that regular LA is associated with very low and compared to pre LA reduced incidence rates of cardiovascular events compared to the period before LA initiation. LA has been proven to be safe, with a low incidence of adverse effects observed over a 13-year period. The number of enrolled patients and the length of follow-up establish GLAR not only as the largest LA registry worldwide. Further efforts are needed to narrow the gap between the number of enrolled and analyzable patients.